BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM AND BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR

by EBI, L.P.

On Feb 24, 2014, the FDA received a filing from EBI, L.P. for a 30-day notice of process change: manufacturing. On Mar 26, 2014, the NE review committee issued the following statement with the approval order:

ALTERNATE-SECONDARY SUPPLIER.

The review and decision took 30 days.

Trade Name BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM AND BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR
Generic Name NON-INVASIVE BONE GROWTH STIMULATOR
Applicant EBI, L.P.
P850022
Contact 399 JEFFERSON ROAD

PARSIPPANY, NJ, 07054
Product Code LOF

Previous Supplements

SupplementApprovals
S020
Sep 12, 2013
APPROVAL FOR IMPLEMENTING A COMPLIMENTARY QUALITY CONTROL PROCEDURE.
S018
Aug 11, 2011
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE (REAL-TIME PROCESS)
APPROVAL FOR THE MODIFICATION OF THE SYSTEM SOFTWARE TO INCLUDE AN ADDITIONAL LINE OF CODE WHICH WOULD ALLOW THE REAL-TIME CLOCK TO RESET TO 'DAY ZERO' AFTER AN ELAPSED 365 DAYS, THIS RESET WOULD ALLOW YOUR DEVICE TO REMAIN FUNCTIONAL AFTER 365 DAYS OF INACTIVITY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM AND SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM AND ARE INDICATED FOR THE FOLLOWING: 1) THE BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM IS INDICATED FOR THE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALL FLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECT IS LESS THAN ONE-HALF THE WIDTH OF THE BONE TO BE TREATED. A NONUNION IS CONSIDERED TO BE ESTABLISHED WHEN THE FRACTURE SITE SHOWS NO VISIBLE PROGRESSIVE SIGNS OF HEALING; AND 2) THE BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM IS INDICATED AS AN ADJUNCT ELECTRICAL TREATMENT TO PRIMARY LUMBAR SPINAL FUSION SURGERY FOR ONE OR TWO LEVELS.
S017
Oct 15, 2010
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT (NORMAL 180 DAY TRACK)
APPROVAL FOR CHANGES TO THE HARDWARE, SOFTWARE, COMPONENTS, AND SPECIFICATIONS OF THE DEVICE.
S016
Jul 27, 2006
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT (NORMAL 180 DAY TRACK)
APPROVAL FOR THE FOLLOWING DEVICE MODIFICATIONS: 1) THE STIMULATOR HAS BEEN MODIFIED TO INCLUDE: A) A NEW USER INTERFACE (SIMILAR TO P850022/S015). THE USER INTERFACE INCLUDES AN ALARM BUTTON, YELLOW LED, AND A LCD DISPLAY TO INDICATE TREATING STATUS; B) AN AUDIBLE AND VISIBLE SELF-CHECKING ALARM MECHANISM WITH ADDITIONAL MALFUNCTION SOURCE INDICATORS (SAME AS P850022/S015). THE AUDIBLE ALARM MECHANISM CAN BE DISABLED USING THE ALARM BUTTON; C) A NEW MAIN PCB CIRCUIT BOARD (SAME AS P850022/S015); D) SOFTWARE C PROGRAM LANGUAGE (SAME AS P850022/S015); E) AN ELAPSED TIME ACCUMULATOR/PATIENT MONITORING FUNCTION (SIMILAR TO P850022/S015). AFTER 270 DAYS OF ELAPSED TREATMENT TIME OR 400 DAYS OF TOTAL ACTIVATION TIME THE 7UNIT WILL NO LONGER GENERATE A SIGNAL. 2) THE POWER SOURCE HAS BEEN MODIFIED FROM A DISPOSABLE BATTERY TO A RECHARGEABLE NIMH "AA" BATTERY. THE DEVICE INCLUDES TWO RECHARGEABLE BATTERIES AND A SINGLE CELL BATTERY CHARGER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ORTHOPAK2 BONE GROWTH STIMULATOR SYSTEM AND IS INDICATED FOR THE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALL FLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECT IS LESS THAN ONE-HALF THE WIDTH OF THE BONE TO BE TREATED. A NONUNION IS CONSIDERED TO BE ESTABLISHED WHEN THE FRACTURE SITE SHOWS NO VISIBLE PROGRESSIVE SIGNS OF HEALING.
S015
Jan 12, 2004
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE (NORMAL 180 DAY TRACK)
APPROVAL FOR A MODIFIED VERSION OF THE BIOELECTRON SPINALPAK FUSION STIMULATOR. THE MODIFICATIONS ARE: 1) THE CURRENT SPINALPAK IS POWERED BY 1 ALKALINE 9 VOLT BATTERY THAT MUST BE REPLACED DAILY. THE MODIFIED VERSION WILL BE POWERED BY 1 NIMN "AA" RECHARGEABLE CELL. THE CHARGER WILL BE INCLUDED. 2) THE HOUSING HAS BEEN MODIFIED TO ACCOMMODATE FOR A RECHARGEABLE BATTERY AND AN LCD DISPLAY. THE CURRENT SPINALPAK HAS AN LED DISPLAY. THE MODIFIED VERSION WILL HAVE A 6 MESSAGE LCD DISPLAY. 3) THE PCB CIRCUITRY HAS BEEN MODIFIED TO ACCOMMODATE THE LCD DISPLAY AND THE RECHARGEABLE BATTERY PACK. 4) THE ORIGINAL SOFTWARE WAS WRITTEN IN ASSEMBLY CODE. THE MODIFIED VERSION WAS REWRITTEN IN C. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIOELECTRON SPINALPAK II SPINE FUSION STIMULATOR AND IS INDICATED AS AN ADJUNCT ELECTRICAL TREATMENT TO PRIMARY LUMBAR SPINAL FUSION SURGERY FOR ONE OR TWO LEVELS.
S014
May 23, 2003
LABELING CHANGE - INSTRUCTIONS (SPECIAL(IMMEDIATE TRACK))
APPROVAL FOR ADDITIONAL LABELING TO EMPHASIZE THE PROPER USE OF THE DEVICE ELECTRODES.
S013
Oct 10, 2001
LOCATION CHANGE: MANUFACTURER (NORMAL 180 DAY TRACK)
APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT ELECTRO-BIOLOGY, INC., GUAYNABO, PUERTO RICO.
S012
Jul 26, 1999
PROCESS CHANGE: PACKAGING (REAL-TIME PROCESS)
Approval for addition of a 3x5-inch package insert (to be used as a daily patient reminder of the key elements of OrthoPak unit maintenance) into the case of every shipped OrthoPak(R) unit. Each card contains the following information: Bioelectron, Inc., 800-524-0677 Call this number for batteries, electrodes, questions or billing inquiries. 1) Change battery every morning. 2) Change electrodes every 3-7 days or when they will not stick to your skin. Make sure yoru skin is clean and dry before applying new electrodes.
S011
Jul 14, 1998
LABELING CHANGE - INDICATIONS (REAL-TIME PROCESS)
Approval for the following modifications:1)The "tombstone" - No part Number a)Change of indication b)Minor grammatical corrections of labeling 2)The Physician Manual-Part Number 380-0001-0001-844 a)Change of indication b)Removed all references to "Snap-on Electrodes" (obsolete) c)Reduced the number of sizes of foam spacers provided from two to one d)Increased the number of leads provided from two to three (20" lead added) e)Minor grammatical corrections of labeling 3)The Patient Manual - Part Number 380-0002-0001-844 a)change of indication b)removed all references to "Snap-on Electrodes" (obsolete) c)Reduced the number of sizes of foam spacers provided from two to one d)Increased the number of leads provided from two to three (20" lead added) e)added the section "Electrode Retainers" (copied from Physician Manual) f)Minor grammatical corrections. The indication change listed above in each section is as follows: removal of the reference to a nine month clinical study time in the approved labels ("A non-union is considered to be established when a minimum of 9 months has elapsed since injury and the fracture site shows no visible progressives signs of healing for a minimum of 3 months - no change in fracture callus") and to insert language as suggested in the FDA letter of June 3, 1998 ("A nonunion is considered to be established when the fracture site shows no visible progressive signs of healing"). The device as modified, will be marketed under the trade name OrthoPak(R) and is indicated for treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where width of the defect is less than on-half the width of the defect is less than one-half the width of the bone to be treated.
S009
Sep 24, 1999
LABELING CHANGE - INDICATIONS (PANEL TRACK)
Approval for SpinalPak Bone Growth Stimulator. The device is indicated as a noninvasive bone growth stimulator for use as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels.
S008
Aug 06, 1993
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER (NORMAL 180 DAY TRACK)
S007
Mar 09, 1994
LABELING CHANGE - OTHER (NORMAL 180 DAY TRACK)
S006
Dec 13, 1989
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER (NORMAL 180 DAY TRACK)
S005
Feb 24, 1989
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER (NORMAL 180 DAY TRACK)
S004
Sep 17, 1987
LABELING CHANGE - OTHER (NORMAL 180 DAY TRACK)
S003
Dec 16, 1986
OTHER (SPECIAL(IMMEDIATE TRACK))
S001
Oct 08, 1986
OTHER (SPECIAL(IMMEDIATE TRACK))
Feb 18, 1986